Physician Clinical Trial Policy (CTP) Neurological Ischemia Lower Extremity Pain and Swelling

To Evaluate the Efficacy Treatment of Lower Extremity Pathologies Derived From Neurological Ischemia Disorders

Physician Clinical Trial Policy (CTP) to evaluate the efficacy treatment of lower extremity pathologies derived from neurological ischemia disorders using the combination of Monochromatic Infrared Photo Energy (MIRE) and Transcutaneous Electrical Nerve Stimulation (TENS) therapies.

Although there are a number of pain disorders, associated with back, or lower extremity pain and swelling, the American Association of Sensory Electrodiagnostic Medicine (AASEM/ DTSC) study programs will accumulate received data following a protocol of treatment performed for the purpose of eliminating pain, reducing swelling, and accelerating recovery periods as well as to record the success or failure and/or improvement of the malfunctioning body part.

• Condition: Neuropathic Pain, Tingling or Numbness derived from neurological Ischemia

• Intervention: Treatments of Monochromatic Infrared Photo Energy (MIRE) in combination with Electronic Signal Treatment (TENS) therapy

• Study Type: Interventional

• Study Design:

  1. Allocation: Non-Randomized
  2. Endpoint Classification: Efficacy Study
  3. Intervention Model: Single Group Assignment
  4. Masking: Open Label
  5. Primary Purpose: Scientific record of treatment success or failure

Inclusion Criteria:

• In the investigator's judgment, a high probability of 5 year survival and compliance with the study visit schedule.

Ability to comprehend and sign an informed consent document prior to study enrollment.

Exclusion Criteria:

• Any other excluding factors that, according to the investigator's judgment, would preclude enrollment in the study.